bri citi training website instructions · 2020. 6. 23. · bri citi training website instructions...

Rev. 06/05/20 Page 1 of 24

BRI CITI Training Website Instructions IRB Biomedical Ethics and GCP

BACKGROUND

WHAT DO I NEED TO COMPLETE?

WHO IS CONSIDERED KEY PERSONNEL?

HOW DO I REGISTER?

ADDING COURSES

HOW DO I COMPLETE THE REFRESHER COURSE?

DO I QUALIFY FOR AN EXEMPTION?

ADDING CONFLICT OF INTEREST TRAINING?

WHAT IF I LOST MY USERNAME AND PASSWORD?

HOW DO I AFFILIATE WITH VM/BRI?

HOW DO I OBTAIN CME CREDITS?

BACKGROUND The BRI Research Protections Department (RPD) has limited the requirements for IRB Biomedical Ethics and GCP training to one program, the Collaborative Institutional Training Initiative (CITI), for the following reasons:

Ensures standardized training;

24/7 online accessibility;

Electronic documentation of completion provided directly to the RPD;

Semi-annual review and updating of courses and development of new initiatives for the program; and

Used by thousands of institutions and facilities around the world.

You will need to score 80% or higher on each module to fulfill your requirement. If you score lower than 80%, you can re-take the test as many times as you need with no penalty. When

Rev. 06/05/20 Page 2 of 24

you have completed all required modules, a certificate of completion will be automatically emailed to you and the RPD. During the course of completing the modules, if you need assistance, contact the RPD at (206) 342-6917 for guidance. You may also contact the CITI Office at the University of Miami at (888) 529-5929 or by e-mail at [email protected].

WHAT DO I NEED TO COMPLETE?

1. All VM/BRI researchers considered “key personnel” are required to complete the “Basic CITI Course in the Protection of Human Research Subjects” (Basic Course) and Good Clinical Practice (GCP) modules. Certain researchers may qualify for an exemption from GCP training if they do not work with VM/BRI patients or subjects directly, their records or identifiable information, or identifiable samples (see “DO I QUALIFY FOR AN EXCEPTION?”).

2. VM/BRI researchers having completed the “Basic Course”, must complete the “Refresher Course in the Protection of Human Research Subjects” (Refresher Course) and GCP modules every 3 years.

3. Researchers not directly affiliated with VM/BRI (e.g. UW, SCH, FHCRC) may qualify for an exception if they have completed training at their own institution (see “DO I QUALIFY FOR AN EXCEPTION?”).

4. Ensure your institutional email address is set to either your VM or BRI email account. This can be done by clicking on “Profile” under your name in the top right of the main menu. Click on “Edit Profile.”

mailto:[email protected]

Rev. 06/05/20 Page 3 of 24

WHO IS CONSIDERED KEY PERSONNEL? Persons responsible for one or more of the following:

Day-to-day protocol decision-making related to the study conduct;

Participant recruitment, selection and eligibility;

Clarification of the complexities of the protocol to the participant and others;

Collecting participant information and entering data using procedures to maintain privacy and confidentiality;

Ensuring that the rights and welfare of participants are monitored throughout the study.

HOW DO I REGISTER?

1. BRI personnel: Go to citi.benaroyaresearch.org to connect to CITI via your BRI account. 2. VM or external personnel: Go to www.citiprogram.org 3. Click “Register” at the top of the page.

4. Select your organization affiliation by searching for "Virginia Mason (VM)/Benaroya Research Institute at Virginia Mason (BRI) (SSO)", agree to the terms, affirm you are an affiliate, and then click the “Continue to SSO Login/Instructions” button.

file:///C:/Users/cweir/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/7L7FHZNG/citi.benaroyaresearch.orghttp://www.citiprogram.org/

Rev. 06/05/20 Page 4 of 24

5. You will be prompted to enter your username and password for your VM or BRI email address. Once information is entered and verified, registration is complete.

ADDING COURSES To add training modules to your account, follow these steps:

1. Go to www.citiprogram.org (or citi.benaroyaresearch.org to connect to CITI via your BRI account, if applicable).

a. Click “Log In” on the main page.

b. Enter your username and password. If you don’t have these, see section WHAT IF I LOST MY USERNAME AND PASSWORD?

http://www.citiprogram.org/file:///C:/Users/cweir/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/7L7FHZNG/citi.benaroyaresearch.org

Rev. 06/05/20 Page 5 of 24

2. Once signed in, you will be taken to the “Main Menu.”

3. Click the link “Add a Course.”

4. You will be prompted with these options to determine which modules you need to complete:

Rev. 06/05/20 Page 6 of 24

5. Please select the group(s) related to your research activities to view available courses and click the “Next” button. (Note: Only select the “Institutional/Signatory Official Courses” or “IRB Chair” options if you hold those titles at this institution.)

6. IRB Human Subjects Research Page:

a. Select the group appropriate to your research activities: i. Group 1 - Biomedical Research Personnel - This course is suitable for Students,

Investigators and staff conducting BIOMEDICAL RESEARCH with human subjects.

Rev. 06/05/20 Page 7 of 24

The VA module must be completed if you plan to work with subjects at a VA facility.

ii. Group 2 - Social & Behavioral Research Personnel - This course is suitable for Students, Investigators and staff conducting Social & Behavioral Research with human subjects.

iii. Group 3 - Data or Specimens Only Research Personnel (Take only if you will NEVER interact with a human subject or view their PHI.)

iv. Group 4 - BRI IRB Members. (Only if you are a member of the BRI IRB) b. If you only need to complete the GCP course, select the last option c. Select a basic course if you have never taken CITI Ethics training at BRI. You must

first complete an approved basic course to receive credit for completing a refresher course.

7. Once registered, you will be taken to the “Main Menu.” You will see “Courses Ready to

Begin” for each course you still need to take.

Rev. 06/05/20 Page 8 of 24

8. To begin, click on “Start Now”. You will be directed to the “Assurance Statement”.

9. You are required to agree to the “Assurance Statement” before you can begin the

course.

Rev. 06/05/20 Page 9 of 24

10. Follow the instructions to complete each module. Tests are located at the bottom of each module.

Rev. 06/05/20 Page 10 of 24

11. You can retake the tests as many times as needed to obtain a satisfactory score.

Rev. 06/05/20 Page 11 of 24

HOW DO I COMPLETE THE REFRESHER COURSE? Recertification for CITI training must be completed every 3 years for IRB. If you received notification that your training has expired, and you are listed as key personnel on any VM/BRI research studies, you will need to take the CITI “refresher course” and “GCP” at this time:




2. Once signed in, you will be taken to the “Main Menu.” You will see up to three

categories of courses: “Active Courses”, “Courses Ready to Begin”, and “Completed

Courses”.

http://www.citiprogram.org/file:///C:/Users/cweir/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/7L7FHZNG/citi.benaroyaresearch.org

Rev. 06/05/20 Page 12 of 24

3. To begin, click “Start Now” or “Continue Course”. You will be directed to the “Assurance Statement”.

4. You are required to agree to the “Assurance Statement” before you can begin the

course.

Rev. 06/05/20 Page 13 of 24


Rev. 06/05/20 Page 14 of 24


Rev. 06/05/20 Page 15 of 24

DO I QUALIFY FOR AN EXCEPTION? An exemption to the GCP training requirement may be available for “key personnel” that do not work with VM/BRI patients or subjects directly, their records or identifiable information, or identifiable samples. Please email [email protected] with your request for exemption. Be sure to include the IRB number of the study you wish to be exempted from and clearly state will not work with VM/BRI patients or subjects directly, their records or identifiable information, or identifiable samples. An exception is available for “key personnel” completing ethics training at another institution (i.e. outside VM/BRI). The institution must have a current Federal-wide Assurance (FWA) and documentation of training for each person must be provided to the BRI RPD office. Documentation via hardcopy or e-mail is acceptable, or you may provide a web-link to your institution's ethics training listing.

ADDING CONFLICT OF INTEREST TRAINING? All researchers meeting at least one of the criteria below are required to complete/add the “COI – Research Conflict of Interest” training:

Member of Research Oversight Committee (i.e. IRB, IBC, IACUC).

Investigator/Research Personnel on any current of future study (e.g. principal, co- or sub- investigator, or any other person at BRI/VM who is responsible for, or otherwise involved in, the design, conduct, or reporting of research.)

Executive leadership, Senior Manager, Compliance Officer.

Board Members with research oversight responsibilities.

To add training modules to your account, follow these steps:




mailto:[email protected]://www.citiprogram.org/file:///C:/Users/cweir/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/7L7FHZNG/citi.benaroyaresearch.org

Rev. 06/05/20 Page 16 of 24


3. Click the link “Add a Course.”

4. You will be prompted with these options to determine which modules you need to complete:

Rev. 06/05/20 Page 17 of 24

3. Please select the box next to “COI – Research Conflict of Interest” and click the “Next” button.

4. Once registered, you will be taken to the “Main Menu.” Under “Courses Ready to Begin” you will see “COI – Financial Conflicts of Interest Course”.

Rev. 06/05/20 Page 18 of 24

5. To begin, click “Start Now”. You will be directed to the “Assurance Statement”.

6. You are required to agree to the “Assurance Statement” before you can begin the course.


Rev. 06/05/20 Page 19 of 24


WHAT IF I LOST MY USERNAME AND PASSWORD? This should not be an issue for BRI personnel, as the Single Sign-On feature should automatically connect you to CITI through your BRI credentials. If you are VM or other outside personnel, and do not remember your username and/or password, follow these steps:

1. Go to www.citiprogram.org and click “Log In.” 2. Click on “Forgot?” next to the username or password.

http://www.citiprogram.org/

Rev. 06/05/20 Page 20 of 24

3. If you need your username, follow the directions in the section “Retrieve Your CITI

Username” to request your username be emailed to you.

Rev. 06/05/20 Page 21 of 24

4. If you have forgotten your password, follow the directions in the section “Reset Your

CITI Password” to set up a new password.

NOTE: Your username and email address used to complete the Basic CITI ethics course is located on the top of your original course completion certificate. Contact the RPD office at: [email protected] if you need assistance.

HOW DO I AFFILIATE WITH VM/BRI?

If you are new to Virginia Mason or Benaroya Research Institute, and you already have a CITI account through your previous institution:

1. Go to www.citiprogram.org and click “Log In” on the main page.

2. Enter your username and password. If you don’t have these, see section WHAT IF I

LOST MY USERNAME AND PASSWORD?

http://www.citiprogram.org/

Rev. 06/05/20 Page 22 of 24


4. Select the “Add Affiliation” option on “Would you like to affiliate with another institution?”

Rev. 06/05/20 Page 23 of 24

5. Select your organization affiliation by searching for "Virginia Mason (VM)/Benaroya Research Institute at Virginia Mason (BRI)" and then agree to the Terms of Service.

6. You will be prompted to answer basic information about yourself. Once this is complete, you will be affiliated with VM/BRI.

7. Ensure your institutional email address is set to either your VM or BRI email account. This can be done by clicking on “Profile” under your name in the top right of the main menu. Click on “Edit Profile.”

Rev. 06/05/20 Page 24 of 24

HOW DO I OBTAIN CME CREDITS? Six (6) Category I CME credits are available for Physicians, Physician Assistants, Nurse Practitioners and Psychologists who complete the "Basic Course.” The credits are available through the University of Miami Office Continuing Medical Education for a handling fee of $60 - $70. Two (2) Category I CME credits are available for Physicians, Physician's Assistants, Nurse Practitioners and Psychologists who complete the “Refresher Course” for a handling fee of $40 - $50. Please call (888) 529-5929 for information specific to CME credits or see the CITI web-site link https://support.citiprogram.org/customer/portal/articles/1719368 for additional instructions. For additional questions about CITI: support.citiprogram.org
https://support.citiprogram.org/customer/portal/articles/1719368https://support.citiprogram.org/

bri citi training website instructions · 2020. 6. 23. · bri citi training website instructions...

Documents